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NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64

Legacy MEDSearch

Food and Drug Administration for commercial use in the United States. Trauma/ER: The BodyTom 64’s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite. the healthcare subsidiary of Samsung Electronics Co.,

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HeartBeam Announces Acquisition of LIVMOR Assets

Legacy MEDSearch

LIVMOR’s technology was commercially deployed within the VA Healthcare System in Dallas, Texas. LIVMOR’s goals are to dramatically improve patient outcomes and to significantly reduce healthcare system costs with better quality data for diagnosis and treatment of chronic diseases. HeartBeam CEO and Founder. About HeartBeam, Inc.

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How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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Hemosonics Awared FDA 510(k) Clearance for Quantra® Hemostasis System with QSTAT® Cartridge

Legacy MEDSearch

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge.

FDA 95
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Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®

Legacy MEDSearch

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management.

FDA 52
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Lumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

Legacy MEDSearch

a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). Lumicell, Inc., The Lumicell DVS is not commercially available.

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Healthcare Watch July/August 2022

PM360

Another 17% recommended mandating patient recruitment requirements and 14% would like to see the development of a diverse pool of investigators and staff. EPA Administrator Michael Regan said the agency will take more aggressive action against PFAS. Drug Approvals. DC Dispatch: PFAS Are More Harmful Than Originally Stated.